Requirements of informed‐consent to xenotransplantation: a qualitative interview study

Abstract

BackgroundThe aim is to establish xenotransplantation as a possible alternative to allotransplantation. The clinical application requires that patients give their informed consent before the transfer of the xenograft. The first informed‐consent‐documents have already been developed. The International Xenotransplantation Association has formulated recommendations for the informed consent process [1]. Nevertheless, up to now it has not yet been examined empirically under which conditions people are ready to consent to a xenotransplantation and how these can be implemented appropriately in the informed consent process.Aims of the qualitatve study: The aims of the study include: to find out which information patients need to be able to make a decision for or against a xenotransplantation; to investigate how the partners and other family members of possible xenotransplantation patients handle their role and the responsibilites linked to it; to ask physicians about their attitude to xenotransplantations and their opinion about which information patients need to be able to make a decision for or against a xenotransplantation; to contribute to improving informed‐ consent‐documents for xenotransplantation patients. Concept and methodology of the study: People should receive the possibility to express their personal considerations and appraisals of the possibility of a xenotransplantation. Hence, we have chose a qualitative study design. Members of the following groups will be interviewed: patients who are waiting for a suitable organ their family members patients who have already received an organ healthy subjects healthy care providers (especially transplant surgeons) On the one hand, the composition of the sample allows us to gather different perspectives on the requirements of participating in a xenotranplantation trial. On the other hand, we include groups which so far have played a minor role in the socio‐empirical research in the field of xenotransplantation (physicians and members).Prior to the interview, the study participants receive an informed‐consent document for a xenotransplantation. The interview guide covers the following questions: How do people get along with the informed‐consent‐document? What do they think about the possibilities and restrictions linked to the xenotransplantation? Which questions are relevant for potential xenotransplantation patients to make an informed decision? What do family members think about the possibility of a xenotransplantation? How do they handle the restrictions? (e.g. lifelong monitoring) What attitudes have physicians and nursing staff to xenotransplantations? DiscussionThe study is still in the conceptual phase. To improve the study design and the interview guide, a discussion with experts from the field of xenotransplantation is important.Reference[1] Vanderpool H. Y. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes‐ Chapter 7: Informed consent and xenotransplantation clinical trials. Xenotransplantation 2009; 16: 255–262.